Quality Misconceptions

For over a decade now, I've had the distinct pleasure of talking quality with professionals representing a myriad of industries. For the most part, people who reach me are experiencing a quality-related issue and are looking to quickly extinguish the fire and prevent recurrences. Or they may simply want to reduce their overall risks—and costs—by incorporating a specific quality initiative.

Every situation is unique, so it's important to be as knowledgeable as possible regarding the company I'm working with and their respective industry. Whether it's a small business owner, a QA Manager, or a CEO of a large corporation, these initial conversations allow me to customize an action plan that will address the client's needs and concerns.

Recently, I've reflected on these conversations and realized that there are a few common misconceptions regarding quality that consistently surface regardless of what industry I'm working with. So, without identifying my specific thoughts, I reached out to my network of peers in the quality industry to see if they would reach a similar conclusion. Not surprisingly, the same misconceptions surfaced from within their day-to-day experiences.

There were four misconceptions that occurred most often. These include:

• The definition of quality is too subjective and can therefore not be defined.
• Quality is the responsibility of one person or group within a company.
• Quality is an expense.
• QA, QC and testing are the same things.

The definition of quality is too subjective and can therefore not be defined.

When asked what it is I do, it's not uncommon for there to be an awkward glare or two. I've discovered that "quality" is often a concept that people aren't comfortable defining. They simply can't express what it means because they consider it to be too subjective. It's not arguable that the definition is different based on individual perspective. Even Wikipedia has difficulty nailing down just one interpretation!

In Zen and the Art of Motorcycle Maintenance, Pirsig argued that, "even though quality cannot be defined, you know what it is." Looking at it this way, the misconception here lies in the fact that there are a variety of factors (perceptions) from which to consider.

At the end of the day, the definition of quality may vary based on the perspective, but it's certainly definable. If you go on the premise that you can't define it, you're opening yourself up for failure because it then becomes something that can't be measured or controlled. Define what quality means for your organization or purpose so it can be continuously measured and improved.

Quality is the responsibility of one person or group within a company.

Deming said it best. "Quality is everyone's responsibility."

Case study after case study shows us that quality has to be incorporated into the fabric of the organization. It has to be recognized and respected at every level, starting at the top. I've seen too many initiatives fail because no one thinks it's their responsibility. And even if an organization has an excellent QA Manager or QA Department, the effort can be lost if there's no buy-in from others.

It can be agreed upon that QA/QC activities such as standards development, CAPA, testing, inspections, etc. are the responsibility of those within the internal QA unit(s) or often the third-party quality provider. However, this does not support the assumption that responsibility is relinquished from all others. Organization-wide support can make or break any efforts from those deemed directly responsible.

In order to see maximum results from any quality program or initiative, total buy-in from top down is required and not optional. This is best achieved when top management recognizes and reinforces with their support. This starts with strategic planning and is incorporated into the tactical and operational practices as well.

Quality is an expense.

This is a big one, and it's the most difficult hurdle I face when recommending a quality initiative or action. I wish I could give people a crystal ball so they could see into the future and know that they'll reduce not only their risks but their costs as well if they incorporate quality into every process within their organization. Even starting small will produce results, if it's organized and implemented correctly of course.

To clarify, the maximum amount of savings does correlate with an "all in" approach. In my experience, band-aids aren't going to produce long-term results (savings), although I would argue that the initial expense of a quick fix dissolves in the wake of resulting returns.

Don't be scared to invest in quality. You wouldn't consider your 401K an expense, right? Dedicating some resources to avoid a fire is certainly going to be less of an expense than what it's going to cost to put it out. Preventative quality implemented with a solid strategy is worth every penny--enough said.

QA, QC and testing are the same thing.

Thinking QA, QC and testing mean the same thing is a common misconception. While they may be closely related, they do refer to very specific and separate activities and should therefore be differentiated.

Quality Assurance is considered to be a process-oriented set of activities related to ensuring continuous and consistent improvement. It's preventative action that defines the expectations of the process or product. Think of it as the macro-level of quality that defines the strategic intent and guidelines. Common examples might include specification and standards development.

Quality Control is considered to be the product-oriented set of activities designed to evaluate (measure and control) against pre-defined requirements. It includes the actions that will verify the product meets or exceeds expectations. For example, internal audits would be an effective and often required action to verify suppliers are in compliance. Or, pre-production, in-process or final pre-shipment inspections of an order of medical devices would be considered Quality Control.

Testing is a specific example of a Quality Control activity but it wouldn't be accurate to assume they are one in the same. One example is stability testing of new drug substances or products. Or, it might include testing a sample for mean time to failure or service life. It's a component of QC, but there are certainly others.

What does it all mean?

Misconceptions are not uncommon. But, identifying those that occur most often provides an opportunity for everyone to be on the same page. Debunking the four specifically noted in this article will lead to a greater understanding of the quality function within an organization...and that's a good thing. If you define it, invest in it, share in the responsibility and measure/control it, you're on the right track.